Dietary Supplement Containing Lyophilized Diary and Linolenic Acid

ABSTRACT

Described is a dietary supplement and a corresponding method to maintain the nutritional health of mammals, including humans. The composition includes a dried dairy product, typically cream, whole milk, reduced fat milk, cottage cheese, yogurt, or combinations thereof in combination with an oil comprising linolenic acid.

1. CROSS-REFERENCES TO RELATED APPLICATIONS

This divisional application claims the benefit of patent applicationSer. No. 13/963,016 filed on Aug. 9, 2013, which claims the benefit ofprovisional patent application No. 61/681,935 filed on Aug. 10, 2012.

2. FIELD OF THE INVENTION

The present invention relates generally to food supplements and morespecifically to a dietary supplement containing lyophilized diary andlinolenic acid, which is used to treat problems with inflammation andauto-immune diseases.

BACKGROUND OF THE INVENTION Summary of the Invention (Background)

As used herein, “linolenic acid” refers to the two octadecatrienoicacids .alpha.-linolenic acid (an omega-3 fatty acid) and.gamma.-linolenic acid (an omega-6 fatty acid), as well as estersthereof (such as acyl-linolenates, for example triglyceride esters oflinolenic acid, and the like). In short, linolenic acids per se arecarboxylic acids with 18-carbon chains and three cis double bonds:

Linolenic acid is a fatty acid found primarily in vegetable oils. It issold as a dietary supplement for use in humans, principally for treatingproblems with inflammation and auto-immune diseases. Its efficacy totreat such ailments, however, is disputed.

The patent literature describes at least one medicinal use of linolenicacid. See U.S. Pat. No. 7,935,729, issued May 3, 2011, to Harbige et al.Harbige et al. describe treating neurodegenerative diseases byadministering to a patient a triglyceride oil containing both.gamma.-linolenic acid and linolenic acid residues as triglycerideester. The ratio of .gamma.-linolenic acid to linolenic acid residues atthe sn-2 position of the triglyceride is at least 0.8. The amount of.gamma.-linolenic acid residues at the sn-2 position is at least 18%.The oil is administered at a dose sufficient to maintain or elevateTGF-.beta.1 levels in the patient at a therapeutic level.

Accordingly, there is a clearly felt need in the art for a dietarysupplement containing lyophilized diary and linolenic acid, which isused to treat problems with inflammation and auto-immune diseases.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Disclosed herein is a dietary supplement comprising a lyophilized dairycomponent, such as lyophilized cream, whole milk, reduced fat milk,cottage cheese, yogurt, and combinations thereof, which is physicallycombined into a mixture with an oil comprising linolenic acid, and/oresters of linolenic acid, and/or a non-toxic salt of linoleic acid,and/or a mixture thereof. Preferred versions of the supplement contain.alpha.-linolenic acid and/or its esters and/or salts.

Numerical ranges as used herein are intended to include every number andsubset of numbers contained within that range, whether specificallydisclosed or not. Further, these numerical ranges should be construed asproviding support for a claim directed to any number or subset ofnumbers in that range. For example, a disclosure of from 1 to 10 shouldbe construed as supporting a range of from 2 to 8, from 3 to 7, from 1to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.

All references to singular characteristics or limitations of the presentinvention shall include the corresponding plural characteristic orlimitation, and vice-versa, unless otherwise specified or clearlyimplied to the contrary by the context in which the reference is made.

All combinations of method or process steps as used herein can beperformed in any order, unless otherwise specified or clearly implied tothe contrary by the context in which the referenced combination is made.

The methods of the present invention can comprise, consist of, orconsist essentially of the essential elements and limitations of theproducts and methods described herein, as well as any additional oroptional ingredients, components, or limitations described herein orotherwise useful in formulating dietary supplements.

One step in preparing the dietary supplement is to dry a suitable dairycomponent for use in the product. As used herein, the term “dry” or“drying” refers to any method now known in the art or developed in thefuture to convert a liquid product into a corresponding dried productThus, as used herein, drying the dairy product can be accomplished by,for example (and not limitation) evaporation, freeze-drying (i.e.,lyophilization or cryodesiccation), spray drying, and the like.

The dried dairy component is then physically combined with one or moreoils comprising linolenic acid and/or its esters. The preferred oils areselected from the group consisting of safflower oil, grape seed oil,poppy seed oil, sunflower oil, hemp oil, corn oil, wheat germ oil,cottonseed oil, soybean oil, walnut oil, sesame oil, rice bran oil,pistachio oil, peanut oil, canola oil, flaxseed oil (linseed oil), oliveoil, palm oil, cocoa butter, macadamia oil, butter, coconut oil, andcombinations thereof. Thus, the combination is a heterogeneous mixtureof the dried dairy component and the liquid (or semi-liquid) oilcomponent.

The resulting combination may optionally be presented in unit dosageform.

In another version of the supplement, the oil too may be dried, so thatthe combination is in homogeneous powder mixture.

As used herein, the term cottage cheese is used broadly to designate anytype of fresh cheese curd, whether curdled with rennet, or added acid,or heat, or a combination of all three. For example, cottage cheeseincludes traditional, U.S.-style cottage cheese (which is typicallycurdled with rennet) as well as fresh cheese such as quark (made bywarming soured milk until the desired degree of denaturation of milkproteins is met, and then strained), fromage frais, fresh chevre, andthe like. The milk product need not come from cows, but from any dairysource, such as goats, sheep, etc.

It is preferred that the dietary supplement be presented in unit dosageform, such as capsules or tablets. Thus, the dietary supplement may bemanufactured in unit dosage form and may be prepared by any of themethods well-known in the art of the formulation of foods andpharmaceuticals. All methods include the step of bringing the activecompounds into association with one another and optional ingredients,such as carriers, accessory ingredients, and the like. In general, theformulations are prepared by uniformly and intimately bringing the drieddairy and oil components into association with one another and then, ifnecessary, shaping the product into desired unit dosage form.

The recommended in vivo dosage in humans and other mammals dependslargely upon the age and general health of the patient being treated.Determining the optimum dosage for any given mammal is essentially anempirical and ongoing process. The dietary supplement is administeredorally. Because of the differences in ages, size and nature of animals,including humans, the amounts which are safe and effective to improveand maintain the health of any given individual may vary considerably.Linolenic acid is a natural food ingredient and it is relativelynon-toxic. Thus, the dosages that can be administered in the methoddisclosed herein are not overly critical as long as they are enough tobe effective to maintain the overall nutritional health of theindividual being treated, and not so high as to induce a fatintake-related disorder, such as a lipidosis.

Tablets are made by compression or molding, optionally with one or moreaccessory ingredients. Compressed tablets are prepared by compressingthe active compound in a free-flowing form, e.g., a powder or granules,optionally mixed with accessory ingredients, e.g., binders, lubricants,inert diluents, surface active or dispersing agents, using conventionaltabletting machinery. Molded tablets may be made by molding a mixture ofthe combination neat or with a suitable carrier, again usingconventional and well-known molding equipment.

In addition to the aforementioned ingredients, the formulations of thisinvention may further include one or more optional accessoryingredient(s) utilized in the art of dietary formulations, e.g.,diluents, buffers, flavoring agents, colorants, binders, surface activeagents, thickeners, lubricants, suspending agents, preservatives(including anti-oxidants) and the like.

The dosage may also be carried within an orally tolerated capsule, suchas a Caplique-brand capsule.

A suitable effective dose for most conditions ranges from about 1 mg/kgbody weight to about 10 g/kg body weight per day, and is preferably inthe range of from about 10 to about 1000 mg/kg body weight per day, orabout 100 to about 500 mg/kg body weight per day. The total daily dosemay be given as a single dose, multiple doses, e.g., two to six timesper day, or by intravenous infusion for a selected duration. Dosagesabove or below the above-cited ranges are within the scope of theinvention and such dosages may be administered to individual subject ifthe circumstances so dictate.

For example, in a 75 kg mammal, a typical daily dosage might fall withthe range of from about 100 mg to about 100 g per day. If discretemultiple doses are indicated, treatment might typically comprise 4 equalfractional doses given at 8 hour intervals to supply the total dailydosage.

Also disclosed herein is a method of improving the nutritional status ofa mammal, including a human, comprising administering to the mammal adosage of from about 1 mg/kg body weight to about 10 g/kg body weightper day of a dietary supplement comprising, in combination a dried dairyproduct, wherein the dairy product is selected from the group consistingof cream, whole milk, reduced fat milk, cottage cheese, yogurt, andcombinations thereof; in combination with an oil comprising linolenicacid. In the preferred version of the method, the administeredsupplement comprises lyophilized cottage cheese, yogurt, or acombination thereof; in combination with flaxseed oil (linseed oil).

In some versions of the product and corresponding method, theformulation may explicitly exclude components found naturally in dairyproducts, such as lactose. Thus, also disclosed herein is a dietarysupplement consisting essentially of or consisting exclusively of, incombination, a dried dairy product, wherein the dairy product isselected from the group consisting of cream, whole milk, reduced fatmilk, cottage cheese, yogurt, and combinations thereof, wherein thedried dairy product is devoid of lactose or has a reduced lactoseconcentration as compared to its natural state; in combination withlinolenic acid.

In this context, the phrase “a reduced lactose concentration as comparedto its natural state” means that at least about 50%, or at least about60%, or at least about 70%, or at least about 80%, or at least about 90%of the lactose naturally found in the dried dairy product is removedfrom the dried dairy product before the dried dairy product is admixedwith the linolenic acid. In this fashion, the ultimate composition has areduced lactose concentration. Thus, for example, disclosed herein is adietary supplement consisting essentially of or consisting of, incombination: (a) lyophilized cottage cheese, yogurt, or a combinationthereof, in which at least 50% of naturally occurring lactose has beenremoved; in combination with (b) flaxseed oil (linseed oil). Or, forexample, a dietary supplement consisting essentially of or consistingof, in combination: (a) a dried dairy product, wherein the dairy productis selected from the group consisting of cream, whole milk, reduced fatmilk, cottage cheese, yogurt, and combinations thereof, in which atleast 50% of naturally occurring lactose has been removed; incombination with (b) linolenic acid.

It has been found, quite unexpectedly, that the combination of dairy andlinolenic acid greatly improves the general nutritional health andmetabolism of mammals, including humans. Thus, the composition andmethod described herein are useful as dietary supplements to improve andmaintain the nutritional health of humans and other mammals. Thecompositions described herein may be formulated in unit dosages suitablefor human and/or veterinarian uses.

While particular embodiments of the invention have been shown anddescribed, it will be obvious to those skilled in the art that changesand modifications may be made without departing from the invention inits broader aspects, and therefore, the aim in the appended claims is tocover all such changes and modifications as fall within the true spiritand scope of the invention.

I claim:
 1. A dietary supplement comprising: cottage cheese is dried;and flaxseed oil contains linolenic acid, wherein said dried cottagecheese is physically mixed with said flaxseed oil to form a linolenicmixture, said linolenic mixture is lyophilized.
 2. The dietarysupplement according to claim 1, in unit dosage form.
 3. The dietarysupplement of claim 1 wherein: said flaxseed oil is linseed oil.